This invention relates to pharmaceutical compositions containing 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]-cyclohepta[1,2-b ]pyridine (hereinafter "descarbonylethoxyloratadine" or ("DCL") and substantially free of DCL decomposition products, and suitable for oral administration to treat allergic reactions in mammals.
U.S. Pat. No. 4,659,716 discloses descarbonylethoxy-loratadine which possesses antihistaminic properties with substantially no sedative properties. This U.S. Patent also discloses methods of making descarbonylethoxyloratadine, pharmaceutical compositions it and methods of using the compositions to treat allergic reactions in mammals.
U.S. Pat. No. 5,595,997 discloses pharmaceutical compositions and methods for treating allergic rhinitis using descarbonylethoxyloratadine. Co-pending, commonly-owned U.S. patent application Ser. No. 08/886,766, filed Jul. 2, 1997 discloses polymorphs of descarbonyl-ethoxyloratadine and pharmaceutical compositions containing them.
We are aware of no prior art that discloses the pharmaceutical compositions of the present invention.
There is a need to produce pharmaceutical compositions suitable for oral administration to mammals and containing descarbonylethoxyloratadine having constant chemical and physical properties in accordance with exacting health registration requirements of the U.S. and international health registration authorities, e.g., the FDA's Good Manufacturing Practices ("GMP") requirements and the International Conference on Harmonization ("ICH") Guidelines.